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| Name | Class |
|---|---|
| Health Research Foundation | OTHER |
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Prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia.
The elderly population can be expected to increase not only in developed countries, but also in developing countries. Pneumonia is one of the most common causes of death in the elderly.
The investigators conducted a prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia in consecutive elderly patients at a nursing home in Yubari during one year from 2009, with the results in a non-intervention group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral care and vaccines | Experimental | Oral care and pneumococcal plus influenza vaccines |
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| Vaccine | Active Comparator | Influenza vaccine only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000) | Biological | Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pneumonia | Number of Participants with Pneumonia sufferers | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Death From Pneumonia | Number of participants for the death from pneumonia | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Leaving Nursing Home | Numer of resident for leaving nursing home | These participants were followed for the duration of nursing home stay, an average of 22 weeks. |
| Reject Oral Care | Number of resident to reject oral care |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hirofumi Hashimoto, M.D.,Ph.D. | Yubari Health Care Research Center | Study Director |
| Masahiro Hatta, D.D.S. | Yubari Kibounomori | Study Chair |
| Takahiro Ichiki, M.D. | Mukawa town National Health Insurance Hobetsu clinic | Study Director |
| Katsushi Nagamori, M.D. | Yubari Health Care Research Center | Study Director |
| Hiroyuki Morita, M.D. | Yubari Health Care Research Cente | Principal Investigator |
| Masako Hatta, D.D.S. | Yubari Health Care Research Center | Study Director |
| Tomohiko Murakami, M.D. | Yubari Kibounomori | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yubari Kibounomori | Yūbari | Hokkaido | 068-0402 | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Influenza Vaccine | Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.). |
| FG001 | Oral Care With Influenza and Pneumococcal Vaccines |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Influenza vaccination (Flubik HA, 16100EZZ01207000) | Biological | Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day |
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| Influenza vaccination (Flubik HA, 16100EZZ01207000) | Biological | Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day |
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| Specific frequency of oral care | Other | 1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room primary care physicians. At the same time, they taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material. |
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| This participant rejected oral care before treatment, Day 1 |
| Reject Vaccine | Number of resident to reject vaccine | These participants rejected vaccine before treatment, Day 1 |
| Died Before Oral Care Starting | Number of resident died before the start of oral care | This participant was died before treatment, Day 1 |
Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;
1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.
| Pneumonia Diagnosis |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Influenza Vaccine | Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.). |
| BG001 | Oral Care With Influenza and Pneumococcal Vaccines | Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following; 1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Pneumonia | Number of Participants with Pneumonia sufferers | Posted | Number | participants | 1 year |
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| Secondary | Death From Pneumonia | Number of participants for the death from pneumonia | Posted | Number | participants | 1 year |
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| Other Pre-specified | Leaving Nursing Home | Numer of resident for leaving nursing home | These participants were determined as "Not Completed" due to "Leaving nursing home". We excluded these participants from analysis for outcome measure. | Posted | Number | participants | These participants were followed for the duration of nursing home stay, an average of 22 weeks. |
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| Other Pre-specified | Reject Oral Care | Number of resident to reject oral care | This participant was determined as "Not Completed" due to "Reject oral care". We excluded this participant from analysis for outcome measure. | Posted | Number | participants | This participant rejected oral care before treatment, Day 1 |
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| Other Pre-specified | Reject Vaccine | Number of resident to reject vaccine | These participants were determined as "Not Completed" due to "Reject vaccine". We excluded these participants from analysis for outcome measure. | Posted | Number | participants | These participants rejected vaccine before treatment, Day 1 |
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| Other Pre-specified | Died Before Oral Care Starting | Number of resident died before the start of oral care | This participant was determined as "Not Completed" due to "Died before oral care starting". We excluded this participant from analysis for outcome measure. | Posted | Number | participants | This participant was died before treatment, Day 1 |
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1 year
Died in Period from pneumonia
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Influenza Vaccine | Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.). | 8 | 94 | 0 | 94 | ||
| EG001 | Oral Care With Influenza and Pneumococcal Vaccines | Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following; 1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material. | 2 | 105 | 0 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Died in period | Infections and infestations | Non-systematic Assessment | 9 (4.5%) of the 199 eligible participants were death from pneumonia still in period. |
| |
| Died before trial | Infections and infestations | Non-systematic Assessment | One participant was died before trial. |
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small numbers of subjects analyzed
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Masahiro Hatta | Department of Dentistry, Yubari Kibounomori, Japan | +81-123-52-4339 | masahiro.hatta@hotmail.co.jp |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| >=65 years |
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| Male |
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